AmB Dose for Cryptococcal Meningitis

• Status: Not yet recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients.

Amphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Recent retrospective study indicated that longer duration rather than higher dose of AmB is necessary to reduce the mortality of CM. We aimed to explore the efficacy and safety of small dose but longer duration of AmB for the treatment of HIV-associated CM.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Public Health Clinical Center
• Treatments: Amphotericin B; Flucytosine; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• Confirmed HIV infection

• Naive to antiretroviral therapy

• Cryptococcal antigen, smear or culture positive in cerebrospinal fluid

• Agree to participate the study

Exclusion Criteria:

• Having receiving antifungal treatment for ≥3 days

• ALT or AST > 5* upper limit of detection (ULD), or neutrophil< 0.5*10E9 cells/L, or hemoglobin < 90g/L or platelet <50*10E9/L or serum creatinine > ULD

• Pregnancy or breastfeeding

• Concomitant medications that are contraindicated with any research drug

• Any other contraindications for using amphotericin B or 5FC

• Inability to follow-up as accessed by the investigator